Bioequivalence and Bioavailability Forum

History Lesson: FDA NDA Submission back in the 50s jag009 2013-03-19 20:42
- History Lesson: FDA NDA Submission back in the 50s drgunasakaran1 2013-03-20 07:35

Selection of PI Irukulla Shravan Kumar 2013-03-19 11:17
- Selection of PI Ohlbe 2013-03-19 12:24
- Selection of PI ElMaestro 2013-03-19 13:11

Temperature and Relative Humidity Conditions Irukulla Shravan Kumar 2013-03-19 04:59
- Temperature and Relative Humidity Conditions ElMaestro 2013-03-19 09:47
  - Temperature and Relative Humidity Conditions Irukulla Shravan Kumar 2013-03-19 09:54

Centrifugation Timings Irukulla Shravan Kumar 2013-03-18 07:02
- Centrifugation temperature ElMaestro 2013-03-18 14:51
  - Centrifugation temperature Helmut 2013-03-18 16:46
    - Centrifugation temperature Ken Peh 2013-03-18 17:45
      - Centrifugation temperature Ohlbe 2013-03-18 18:44
      - rpm vs. ×g Helmut 2013-03-18 23:14
        
        rpm vs. ×g Irukulla Shravan Kumar 2013-03-19 05:00

Check list for Chile Audit Irukulla Shravan Kumar 2013-03-18 07:16
- Check list for Chile Audit drgunasakaran1 2013-03-18 10:16
  - Check list for Chile Audit Irukulla Shravan Kumar 2013-03-18 11:04
    - Check list for Chile Audit drgunasakaran1 2013-03-18 11:16

T-License obtained for invitro testing dpksangwan 2013-03-12 13:47
- T-License obtained for invitro testing cakhatri 2013-03-12 18:15
  - T-License obtained for invitro testing dpksangwan 2013-03-18 06:40
    - T-License obtained for invitro testing drgunasakaran1 2013-03-18 10:23

Retention quantity for health canada suchit_bhavsar 2013-03-14 12:36

Sulindac Metabolites Noha Abdeljawad 2013-02-26 09:08
- Which agency? Helmut 2013-02-26 15:33
  - Which agency? Noha Abdeljawad 2013-03-05 11:11

Biowaiver cakhatri 2013-02-28 11:37
- FDCs biowaiver (Class I/III) Helmut 2013-02-28 17:56

FDA dropout guideline for Emesis jag009 2013-02-19 16:16
- Median tmax Helmut 2013-02-19 17:49
  - Median tmax jag009 2013-02-19 19:49
    - Median tmax Helmut 2013-02-19 20:28
      - Median tmax jag009 2013-02-19 21:18
        
        Intellectual horsepower Helmut 2013-02-19 21:49
        
        Intellectual horsepower jag009 2013-02-19 22:45
        Intellectual horsepower jag009 2013-02-20 16:12
        
        Intellectual horsepower Helmut 2013-02-20 17:03
        
        Intellectual horsepower jag009 2013-02-20 22:05
      - Median tmax luvblooms 2013-02-20 05:03
        
        Sorry for the overgeneralization Helmut 2013-02-20 16:54
        
        overgeneralization ???? luvblooms 2013-02-21 05:23
        
        overgeneralization ???? Helmut 2013-02-21 12:17
        overgeneralization ???? jag009 2013-02-21 16:55
  - Median tmax intuitivepharma 2013-02-28 13:05
    - Median tmax from pilot studies Helmut 2013-02-28 14:02

Partial Replicate Study Design (subjects considered for PK) sandipmumbai 2013-02-26 11:03
- Partial Replicate Study Design (subjects considered for PK) Dr_Dan 2013-02-26 13:08
- Partial Replicate Study Design (subjects considered for PK) Ohlbe 2013-02-26 13:29
- incomplete data (without T) Helmut 2013-02-26 14:38
  - incomplete data (without T) sandipmumbai 2013-02-27 07:29

TMFs: Reflection paper Helmut 2013-02-20 17:26
- Bioanalytical CROs, GCP, TMF - longish ElMaestro 2013-02-20 20:00
  - Bioanalytical CROs, GCP, TMF - longish Debbie 2013-02-21 17:53
  - GCP, GLP, GCLP Ohlbe 2013-02-21 19:30
    - GCP, GLP, GCLP ElMaestro 2013-02-21 20:41
      - GCP, GLP, GCLP Ohlbe 2013-02-26 00:01

Screening Validity period sumit 2013-02-22 13:40
- Screening Validity period Helmut 2013-02-22 17:14

new strength olacy 2012-11-07 10:46
- new strength Dr_Dan 2012-11-08 10:22
  - new strength ABE1580 2013-02-14 07:11
    - less than proportional increase Helmut 2013-02-14 12:58
      - less than proportional increase ABE1580 2013-02-16 11:21

ANVISA Guideline avinash 2013-02-14 09:47

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